Biosimilars are already widely in use in
Europe. EMA lists the following products [1]: Amgevita (adalimumab), Benepali
(etanercept), Flixabi (infliximab), Inflectra (infliximab), Remsima (infliximab),
Solymbic (adalimumab), Truxima (rituximab).
There have been 69 abstracts addressing
different aspects of biosimilars. Immunogenicity was of concern. Lots of
comparative studies of biosimilars vs. originator have been done. I’ve seen a meta-analysis.
I think cost saving is the driving motive to use biosimilars. And making money
drives the other side. I won’t comment on all these studies, instead I’ll show
you just one study with remarkable results.
B. Glintborg and colleagues presented the
following study [2]: “PRESCRIPTION PATTERNS OF BIOLOGICAL DISEASE MODIFYING
DRUGS AND BIOSIMILARS IN ANKYLOSING SPONDYLITIS – A COLLABORATION BETWEEN
BIOLOGICAL REGISTERS IN THE FIVE NORDIC COUNTRIES”. Conclusions: “The use of
bsDMARDs in AS is rapidly increasing. The use of drugs with new modes of action
is still low, which illustrates the need for collaboration across countries to
provide real life data with sufficient power for new innovative therapies in
the future.” The interesting part is the picture. If an infliximab biosimilar
is introduced, one would assume that originator infliximab is prescribed less
frequently. That happened, but at a slower rate than expected. Also the etanercept
biosimilar soared up after introduction. Interestingly this has led to a reduction
in prescribing not only of etanercept originator but also of the infliximab
biosimilar. But a strange thing happened – the rate of prescriptions for
adalimumab, golimumab, and certolizumab decreased rapidly in the wake of the
introduction of biosimilars; the drop even accelerated after the launch of the etanercept
biosimilar.
Politicians were hoping in the advent of biosimilars,
that eventually prices drop. I have my problems with this view as tofacitinib and
baricitinib are marketed on the current level of biologics. Maybe I’m wrong and
biosimilars will lead to a lower level of costs for needed drugs in
rheumatology.
Links and
References:
[2] http://scientific.sparx-ip.net/archiveeular/?searchfor=B.%20Glintborg%20&c=a&view=1&item=2017THU0361
DOI: 10.1136/annrheumdis-2017-eular.1891
.
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